secwatch.observer — SEC 8-K summary
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Issuer:     ZEVRA THERAPEUTICS, INC. (ZVRA)
CIK:        0001434647
Form:       8-K
Filed at:   2024-07-09T23:59:59+00:00
Accession:  0001437749-24-022362
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zevra announces FDA advisory committee meeting for arimoclomol on Aug 2, 2024
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- FDA's Genetic Metabolic Diseases Advisory Committee (GeMDAC) will review arimoclomol NDA for Niemann-Pick disease type C.
- Meeting scheduled for August 2, 2024; background materials released two business days prior.
- PDUFA action date for arimoclomol is September 21, 2024.
- Arimoclomol is an orally delivered, first-in-class treatment for NPC, a rare genetic disease.
- Zevra CEO highlights opportunity for NPC community to share treatment needs with the advisory committee.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924022362/0001437749-24-022362-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924022362/zvra20240614_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-022362

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer